University of California San Francisco researchers say only one of 15 oncologic drug surrogate analyses conducted by FDA showed a correlation between ...
FDA publishes a guidance on how it will exercise oversight over select software functions in mobile and general purpose computing applications.
FDA announces a collaborative effort with the Veterans Health Administration to speed medical device innovation by developing new tests for product sa...
FDA issues Avidity Biosciences a partial clinical hold on new participant enrollment in its Phase 1/2 MARINA clinical trial of AOC 100 in adults with ...
Two stakeholders give FDA technical comments on a guidance based on an International Council for Harmonization guideline on drug interaction studies.
FDA publishes a guidance on 510(k) submissions for computer-assisted detection devices applied to radiology images and device data.
FDA issues a revised final guidance entitled Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiol...
FDA releases the form FDA-483 with five observations from an inspection at the Ripley, MS-based Delta Pharma outsourcing facility.
